The Australian Government has recently implemented the Therapeutic Goods Legislation Amendment (2019 Measures No. 1) Regulations 2019 (Amendment Regulations).

The Amendment Regulations introduce a broad range of amendments but we will focus on the impact of the amendments on two key areas: (1) the new classification rules affecting software in medical devices and Software as a Medical Device (SaMDs); and (2) the re-classification of certain active medical devices.

1. New classification rules for Software

The regulation of medical device software and SaMDs has been high on the regulatory agenda for quite some time with the TGA conducting public consultation on the regulation of software and SaMDs in early 2019.

Medical device software has well and truly moved on from the time where it was largely developed by medical device manufacturers and embedded in medical devices to control its functions. Now that smartphones and tablets have become ubiquitous, stand-alone software that rely on algorithms using artificial intelligence (AI) or Machine Learning (ML) that can inform, drive or replace clinical decisions, or that could directly provide therapy to a patient, is now commonplace. The current medical device classification rules were drafted based on the potential risk of harm to patients caused by a physical interaction with a device, which has limited applicability to SaMDs and does not specifically consider information as the source of harm.

Software that processes data to provide information to be used to diagnose or treat a person can cause harm if the information is incorrect. Most medical devices that consist of software are currently classified as Class I. This is the lowest risk classification and yet could conceivably apply to software incorporating advanced processes such as "learning" over time as a result of AI or ML algorithms, making ongoing post market performance monitoring particularly important for such devices.

In recognition of these challenges, the Amendment Regulations introduce new classification rules specifically designed for programmed or programmable medical devices and SaMDs that are intended to more accurately classify such products based on the level of risk they may pose to public health. For example, if a device is intended to provide a diagnosis of, or screen for, a disease or condition that may lead to death or a severe deterioration in a person's health, these will be classified as Class III devices. If they pose a moderate risk to public health, they will be classed as Class IIb devices. The classification of medical devices will also be dependent on who the recipient of the information will be (i.e. will the recipient be a healthcare professional or a lay consumer).

The Amendment Regulations also introduce additional classification rules for programmed or programmable medical devices and SaMDs that are intended to monitor the state or progression of a disease/condition, used in specifying or recommending treatment or intervention or that is used to provide therapy to a person through the provision of information.

Changes have also been made to Essential Principle 12 to be more applicable and relevant to programmed or programmable medical device or SaMDs to provide greater clarity to sponsors and manufacturers in respect of the requirements regarding their design and production, the intended operating environment (including cybersecurity and vulnerabilities), safety and performance.

The new changes will commence on 25 August 2020 for new applications for inclusion.

Sponsors of existing affected programmed or programmable medical devices or SaMDs included in the Australian Register of Therapeutic Goods (ARTG) prior to 25 August 2020 or who have filed applications for inclusion prior to that date that are still pending, will have until 1 November 2024 to re-apply for marketing approval for their device under the new classification regime and to bring their devices into compliance with the new requirements provided they notify the Secretary of:

a) the unique device number assigned to that device by the Secretary; and

b) the unique product identifier given to each such device by its manufacturer (if any),

before the later of 25 February 2021 or within 2 months after their device is included in the ARTG. If such a notification is not provided, then the new rules will apply to the above medical devices on and after the later of 25 February 2021 or the date 2 months after the device is included in the ARTG.

The TGA has indicated that it will publish further guidance and information about the new classification rules and transitional arrangements in early 2020.

2. Reclassification of active medical devices

The Amendment Regulations will amend the classification rules so that active medical devices for therapy that are intended by their manufacturer to have an integrated or incorporated diagnostic function that significantly determines patient management will be classed as Class III devices, instead of Class IIa or IIb (under the current classification rules).

The same transitional arrangements apply to affected active medical devices as above for programmed or programmable medical devices or SaMDs.

3. Conclusion: What do you need to do to now?

Overall, the changes provide further clarity to the regulatory requirements applicable to SaMDs and active medical devices for therapy and generally place tighter scrutiny on higher risk forms of these products by up-classification.

Under paragraph 41GN(1)(f) of the Therapeutic Goods Act 1989 (Act), a medical device may be cancelled from the ARTG if a certification made by the sponsor when applying for inclusion in the ARTG is no longer correct – including the certification that would have been made by the sponsor under the Act that their medical devices have been correctly classified.

Sponsors of products that are programmed or programmable medical devices, SaMDs or active medical devices that have been affected by the changes introduced by the Amendment Regulations should review their product classifications and conformity assessment procedures to assess what additional work will be required to ensure that their products comply with the revised classification rules and Essential Principles by the applicable commencement date.

Sponsors of existing medical devices or pending applications should ensure that they do not miss the deadline to make notifications to the Secretary (by the later of 25 February 2021 or within 2 months after their device is included in the ARTG) in order to take advantage of the extended time period (until 1 November 2024) to bring their medical devices into compliance with the new requirements.

Should you have further questions, please contact us.

Thank you to Adaena Sinclair-Blakemore for her help in preparing this alert.

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